The stability of aseptically compounded ready to administer presentations of monoclonal antibody products and other biopharmaceuticals is complex and requires a high degree of expertise in order to carry out and to assess stability studies. The NHS Pharmaceutical Research and Development Group have produced a ‘yellow cover’ standards document entitled ‘A Standard Protocol for Deriving and Assessment of Stability Part 2 – Aseptic Preparations (Biopharmaceuticals)’. This sets out minimum standards required before stability data can be used to support extended (beyond SmPC) shelf lives for these products. For biosimilars there is now often extended shelf-life data within the product SmPC and this has been included below for completeness.
Stability data generated to support extended shelf lives of monoclonal antibodies is specific to the process tested and is only applicable provided that specified handling of the products is maintained.
The stability data under CDAs from several commercial aseptic compounders and also from the MIA holders for various agents has been reviewed. Within the table below is a summary of those products reviewed and the shelf life supported together with applicability and any clarification notes. Expiry periods (shelf lives) assigned to products should be evaluated in accordance with local conditions, formulations and practices. In no circumstances should an expiry period of seven days be exceeded for products prepared in unlicensed aseptic units – see Chapter 6, Quality Assurance of Aseptic Preparation Services.
Attachment for biopharmaceutical stability data
- Version 5: Information for additional products added. Information for some products updated. Statement "Those marked applicable for one supplier only are only applicable to products compounded by that company as the data is confidential to them" added